P.F.C. SIGMA 95-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295230458), received between Nov 10, 2017 and Mar 20, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18940308 ↗
• InjuryAug 4, 2023Naturally Worn; Naturally Worn

  THIS INSERT HAS WORN OVER MANY YEARS OF USE AND REQUIRES REPLACEMENT WITH A CUSTOM IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 17458115 ↗
• InjuryOct 12, 2022Naturally Worn; Naturally Worn

  PATIENT UNDERWENT PRIMARY BILATERAL KNEE REPLACEMENT ON 29/11/2007 WHERE A PFC RPF WAS UTILISED. THE PATIENT HAS REPORTED THAT HIS RIGHT KNEE HAS NEVER BEEN AS GOOD AS HIS LEFT KNEE. THE PATIENT HAS PRESENTED TO DR S.S. WITH PAIN IN HIS RIGHT KNEE. DR S. UNDERTOOK AN EXPLORATORY KNEE ARTHROSCOPY (DATE UNKNOWN) AND FELT THAT THE KNEE HAD SOME OSTEOPHYTES AND POLY WEAR PRESENT. ON OPENING THE KNEE (DR S., PINDARA PRIVATE) THE KNEE WAS FOUND TO BE WELL FIXED. THERE WERE SIGNS OF WEAR ON THE TOP OF THE POLY SPINE (PART OF THE SPINE AND CAM) THERE WAS ALSO EVIDENCE OF WEAR AROUND THE PATELLA BUTTON. THE OSTEOPHYTES AROUND THE POSTERIOR PART OF THE KNEE WERE REMOVED AND BOTH THE POLY INSERT AND THE PATELLA REMOVED. AS THE KNEE WAS NOW SLIGHTLY LOOSER (WITH THE OSTEOPHYTES REMOVED) A SLIGHTLY THICKER 12.5MM INSERT WAS IMPLANTED. A NEW PATELLA COMPONENT WAS ALSO IMPLANTED. THERE WERE NO SIGNS OF INFECTION. DOI: (B)(6) 2007. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15587578 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6), SUBJECT ID: (B)(4). ASSOCIATED STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION DEEP. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015, DATE OF EVENT (ONSET): (B)(6) 2015, (RIGHT KNEE). TREATMENT: RIGHT KNEE IRRIGATION & DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 13266528 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOSS OF MOVEMENT IN KNEE POST TOTAL KNEE REPLACEMENT. NEEDED MANIPULATION UNDER ANAESTHETIC: ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF EVENT (ONSET): (B)(6) 2015. (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA, CELESTONE & NAROPIN INJECTION, PHYSIOTHERAPY.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties

  MAUDE report 13266320 ↗
• MalfunctionJan 20, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE INTERNAL BAG CONTAINING THE IMPLANT WAS PERFORATED AT SEVERAL LOCATIONS. THE EXTERNAL RIGID PACKAGE WAS NOT DAMAGE. THE STERILITY IS NOT GUARANTEED. THE IMPLANT HAS NOT BEEN USED. ANOTHER DEVICE HAS BEEN USED. ISSUE NOTICED BEFORE THE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11201514 ↗
• InjuryJan 4, 2021Naturally Worn; Naturally Worn

  PATIENT UNDERWENT LEFT PRIMARY TKR IN 2006. AT THIS TIME A PRIMARY PFC RPF FEMORAL COMPONENT SIZE 5 LEFT AND A CEMENTLESS DUOFIX MBT TRAY WAS UTILISED (CAT NUMBERS AND LOT NUMBERS COULD NOT BE ESTABLISHED). PATIENT HAS DONE WELL FOR A NUMBER OF YEARS (UNDERTAKING MANUAL WORK) AND STARTED TO FEEL PAIN IN THE LAST 2 YEARS. X-RAYS SHOW A LOOSE FEMORAL COMPONENT ALONG WITH WEAR OF THE TIBIAL INSERT ON THE MEDIAL SIDE. ON OPENING THE KNEE THE FEMORAL COMPONENT WAS OBVIOUSLY LOOSE (THIS COMPONENT HAD DEBONDED AT THE IMPLANT CEMENT INTERFACE AND SHOWED SIGNED OF POLISHING WHERE THERE HAD BEEN MOVEMENT BETWEEN THE CEMENT AND THE IMPLANT). GRANULOMAS SOFT TISSUE WAS EXCISED FROM THE EXTENSOR MECHANISM, AND THERE WERE ETEOLYTIC LESIONS IN THE DISTAL FEMORAL BONE. THE DUOFIX TRAY WAS NOT OVERTLY LOOSE BUT DID COME AWAY FROM THE TIBIAL BONE WITHOUT TOO MUCH EFFORT. THE PATELLA COMPONENT WAS LEFT IN SITU. AN ATTUNE REVISION COMPONENT WAS IMPLANTED ALONG WITH BOTH FEMORAL AND TIBIAL SLEEVES. GOOD STABILITY AND FIXATION WERE ACHIEVED.

  Patient problems: Osteolysis; Pain

  MAUDE report 11113528 ↗
• InjuryNov 13, 2020Unintended Movement; Unintended Movement

  CLINICAL COMPLAINT (B)(4). LEFT KNEE REVISED ON (B)(6) 2015, DUE TO SPIN-OUT. ORIGINAL SURGERY DUE TO OSTEOARTHRITIS.

  Patient problems: No Code Available

  MAUDE report 10836429 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8339186 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS DOING EXTREMELY WELL UNTIL APPROXIMATELY (B)(6) 2018, WHERE HE REPORTED DOING A "MINOR EXTENSION ACTION WHEN PUSHING A TROLLEY. HE HAD IMMEDIATE ONSET OF PAIN. HE IS UNABLE TO WALK UP AND DOWN STAIRS WITHOUT PAIN AND AN ABLE TO SIT FOR PROLONGED PERIODS OF TIME. HE IS AWARE OF A CLICKING AND CATCHING SENSATION. X RAYS APPEAR TO SHOW THAT THE COMPONENTS ARE WELL FIXED AND THAT THERE MAY BE A SLIGHTLY OBLIQUE RESECTION OF THE PATELLA WHEN THE PATELLA WAS RESURFACED AT TIME OF PRIMARY SURGERY. A DECISION HAS BEEN MAKE TO OPEN THE KNEE AND REMOVE THE EXISTING PATELLA, RECUT THE PATELLA BONE AND THEN RESURFACE THE PATELLA. ON OPENING THE KNEE ALL COMPONENTS WERE WELL FIXED. SCAR TISSUE SURROUNDED THE PATELLA BUTTON. THE KNEE WAS SLIGHTLY LOOSE THROUGH THE RANGE OF MOTION, THE POLY WAS REMOVED AND UP SIZED TO A THICKER 12.5MM INSERT. PATELLA WAS REMOVED AND REPOSITIONED. A NEW 41MM PATELLA WAS INSERTED.

  Patient problems: Loss of Range of Motion; Not Applicable; Pain; Scarring

  MAUDE report 7742027 ↗
• InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL KNEE REVISION, (B)(6), (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2008. REVISION WAS PAIN DUE TO POSSIBLE LOOSENING OF FEMORAL IMPLANT AS MANIFESTED BY RADIO-TRANSLUCENT LINE AROUND FEMUR ON X-RAY. PATIENT PRESENTED WITH PAIN IN LEFT KNEE TO SURGEON A FEW MONTHS AGO. PATIENT HAD A PRIMARY CEMENTED PFC RPF IN BILATERAL KNEES, HOWEVER ONLY SYMPTOMATIC IN THE LEFT. UPON X-RAY, SURGEON NOTED A RADIO-TRANSLUCENT LINE AROUND THE FEMUR, POSSIBLE INDICATION OF LOOSENING. DURING REVISION, SURGEON INDICATED THAT THE FEMUR WAS NOT LOOSE, HOWEVER STILL CHOSE TO REVISE THE KNEE WITH A TC3/MBT STEMS AND SLEEVES. XRAYS AVAILABLE. MALE PATIENT INITIALS: (B)(6), AGED (B)(6) YEARS, DOB: (B)(6). (UNKNOWN (B)(4): NO PRODUCT CODE: PFC RPF: NO LOT #). (B)(4) REPRESENTATIVE WAS PRESENT AT REVISION. DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7521787 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7464342 ↗
• InjuryNov 10, 2017Break; Break

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT IS USED. IT ALSO STATES THAT UPON EXPOSURE THERE WAS A NOTABLE SHEARING ON THE LATERAL SIDE OF THE INSERT. ALSO, THE COMPLETE DE-BONDING OF CEMENT FROM BOTH FEMORAL AND TIBIAL PROSTHESIS. UPDATE REC'D NOVEMBER 03, 2017 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THERE IS NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME. THE COMPLAINT WAS UPDATED ON: 11/09/2017.

  Patient problems: No Code Available; Pain

  MAUDE report 7017728 ↗